NCT04831723

Brief Summary

The aim of this feasibility laboratory study is to evaluate whether the laboratory testing pathway for glucose screening in newborn blood spots (NBS) can be done at scale, and that the glucose test has a carefully established cut-off to define what level glucose is abnormal at day 5 of life. The investigators aim to run this feasibility study for a period of 6 to 12 months to fully embed and test the process. This will equate to assessing glucose levels in approximately 10,000 NBS samples. The results from this study will inform a future large scale prospective screening study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,784

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

July 9, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

12 months

First QC Date

April 1, 2021

Last Update Submit

May 3, 2023

Conditions

Neonatal Diabetes

Outcome Measures

Primary Outcomes (1)

  • Normal range of capillary blood glucose in newborns at day 5 of life

    12 months

Secondary Outcomes (1)

  • Validation of laboratory procedures

    12 months

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Babies having a routine NBS screening test within the areas served by the Portsmouth regional screening laboratory (NHS Trusts within Hampshire, Dorset \& parts of Wiltshire)

You may qualify if:

  • Babies having a routine NBS screening test.
  • Routine maternity care team within the area served by the Portsmouth regional screening laboratory (NHS Trusts within Hampshire, Dorset \& parts of Wiltshire)

You may not qualify if:

  • Parent decides to opt-out of the blood glucose test feasibility study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dorset County Hospital

Dorchester, United Kingdom

Location

University Hospitals Dorset

Poole, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, United Kingdom

Location

University Hospital Southampton

Southampton, United Kingdom

Location

Study Officials

  • Timothy Mcdonald

    Royal Devon and Exeter NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 5, 2021

Study Start

July 9, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(4)